CN115486975A

Movatterモバイル変換

Info

Publication number: CN115486975A
Application number: CN202211229353.XA
Authority: CN
Inventors: 王留香
Original assignee: Zhengzhou University
Current assignee: Jinan Fenghua Medical Technology Co ltd
Priority date: 2022-10-08
Filing date: 2022-10-08
Publication date: 2022-12-20
Anticipated expiration: 2042-10-08
Also published as: CN115486975B

Abstract

Translated fromChinese

本发明涉及医疗器械领域，公开了一种用于颈椎的分体式椎间融合器，适用于治疗和改善颈椎先天疾病、畸形、退行性疾病、颈椎椎间盘突出及颈椎骨折等疾病，有效解除神经压迫、改善临床症状，达到更好的融合效果。

The invention relates to the field of medical equipment, and discloses a split-type intervertebral fusion device for cervical vertebrae, which is suitable for treating and improving cervical vertebrae congenital diseases, deformities, degenerative diseases, cervical disc herniation and cervical vertebrae fractures, and effectively relieves nerve compression , Improve clinical symptoms and achieve a better fusion effect.

Description

Translated fromChinese

一种用于颈椎的分体式椎间融合器A split-type intervertebral fusion device for cervical spine

技术领域technical field

本发明涉及医疗器械领域，尤其是一种用于颈椎的分体式椎间融合器，适用于治疗和改善颈椎先天疾病、畸形、退行性疾病、颈椎椎间盘突出及颈椎骨折等疾病，有效解除神经压迫、改善临床症状，达到更好的融合效果。The invention relates to the field of medical devices, in particular to a split-type intervertebral fusion device for the cervical spine, which is suitable for treating and improving cervical spine congenital diseases, deformities, degenerative diseases, cervical disc herniation and cervical fractures, and effectively relieves nerve compression , Improve clinical symptoms and achieve a better fusion effect.

背景技术Background technique

由于各种原因所致的颈椎椎间盘退行性病变及创伤常会导致椎间盘突出，破坏椎间盘结构的完整性，使椎间盘丧失其原有的运动及承载负荷的功能，给人们带来疼痛、神经功能障碍等症状，严重影响了人们的日常活动，当颈椎椎间盘疾病保守治疗无效时，一般应进行手术治疗。目前常用的手术方法包括间盘髓核摘除术和间盘切除植骨融合术等，但无论是前者还是后者均破坏了病变节段的正常运动及承载功能，同时也改变了相邻节段椎间盘和其它组织的生物力学状态，导致了邻近节段退变加剧，因此其远期疗效均欠佳，为此，人们发明了人工椎间盘假体以重建椎间盘功能，恢复颈椎正常生理功能。Cervical intervertebral disc degeneration and trauma caused by various reasons often lead to intervertebral disc herniation, destroying the integrity of the intervertebral disc structure, causing the intervertebral disc to lose its original function of movement and load bearing, and bringing pain and neurological dysfunction to people. Symptoms have seriously affected people's daily activities. When conservative treatment of cervical disc disease fails, surgical treatment should generally be performed. At present, the commonly used surgical methods include discectomy and discectomy and bone graft fusion, but both the former and the latter destroy the normal movement and bearing function of the diseased segment, and also change the adjacent segments. The biomechanical state of the intervertebral disc and other tissues has led to aggravated degeneration of adjacent segments, so its long-term efficacy is not good. Therefore, artificial intervertebral disc prosthesis has been invented to reconstruct the function of the intervertebral disc and restore the normal physiological function of the cervical spine.

椎间融合器作为常用的可植入人工椎间盘假体，其在材料性能上有一些特殊要求，比如必须具有良好的生物相容性、无毒性、无致癌性、耐腐蚀性，在植入后不会引起局部的组织反应，这是人工椎间盘假体材料的基本要求，另外，从生物力学方面考虑，由于椎间盘在生理状态下要承受压缩、弯曲、扭转、剪切等多种负荷，是脊柱功能单位的负载活动轴心，因此材料还必须具有高强度、耐磨性、抗疲劳性等性能条件，人工椎间盘假体的终板件与椎体终板骨质相接触，其接触界面的弹性模量应尽量匹配，即终板件的弹性模量应与骨组织相近，这样才能有效避免内植物的沉陷和松动，目前已有多种人工椎间盘假体，根据组成材料的不同可以将人工椎间盘分为3种：即非金属、金属和两者的结合体。除了上述材料上的要求之外，在运动性、稳定性、安全性等方面也具有较为严格的要求，人工椎间盘假体在植入时需获得即刻固定和长久固定，在使用时应尽量恢复置换节段的生理活动性能，包括在多个方向上的活动范围、旋转轴心，使人工椎间盘假体与邻近多个节段的脊柱运动同步，其次人工椎间盘假体在使用时还应使安装方便安全、手术创伤小、易于拆除和假体翻修，从而在临床治疗上发挥应有的作用。As a commonly used implantable artificial intervertebral disc prosthesis, the intervertebral fusion device has some special requirements on material properties, such as good biocompatibility, non-toxicity, non-carcinogenicity, and corrosion resistance. It will not cause local tissue reaction, which is the basic requirement of the artificial intervertebral disc prosthesis material. In addition, from the perspective of biomechanics, since the intervertebral disc bears various loads such as compression, bending, torsion, and shearing under physiological conditions, it is the backbone of the spine. The load activity axis of the functional unit, so the material must also have high strength, wear resistance, fatigue resistance and other performance conditions. The endplate of the artificial intervertebral disc prosthesis is in contact with the bone of the vertebral endplate, and the elasticity of the contact interface The modulus should match as much as possible, that is, the elastic modulus of the endplate should be similar to that of the bone tissue, so as to effectively avoid the subsidence and loosening of the implant. At present, there are many kinds of artificial intervertebral disc prosthesis, and the artificial intervertebral disc can be made according to the different materials. Divided into three types: non-metal, metal and a combination of the two. In addition to the above material requirements, there are also relatively strict requirements in terms of mobility, stability, safety, etc. The artificial intervertebral disc prosthesis needs to be fixed immediately and permanently when implanted, and the replacement should be restored as much as possible during use. The physiological activity performance of the segment, including the range of motion in multiple directions and the axis of rotation, makes the artificial intervertebral disc prosthesis synchronize with the spinal motion of multiple adjacent segments. Secondly, the artificial intervertebral disc prosthesis should be easy to install when it is used. Safety, less surgical trauma, easy removal and revision of the prosthesis, so it can play its due role in clinical treatment.

然而，由于椎间盘的生理结构和生物力学性能非常复杂，并且缺乏合适的动物模型进行动物研究，因此人工椎间盘的研发较为困难，人们迫切希望获得一种结构合理、材料性能优秀的新型人工椎间盘假体，以便于更好的适用于颈椎的椎间解剖和生物力学性能要求，用以完全替代颈椎椎间盘，治疗颈椎椎间盘疾病，就目前而言，在颈椎椎间融合器的形状设计、固定方式、力学性能改进和骨融合改善等方面仍有较大潜力，仍然存在固定不稳、定位不准、不便操作、力学适应性差、治后易复发、融合效果不理想等诸多问题，我们试图使其越来越接近人们的期望，以期实现良好的临床治疗效果。However, due to the complex physiological structure and biomechanical properties of the intervertebral disc, and the lack of suitable animal models for animal research, the development of artificial intervertebral discs is difficult. People are eager to obtain a new type of artificial intervertebral disc prosthesis with reasonable structure and excellent material properties. , in order to be better applicable to the intervertebral anatomy and biomechanical performance requirements of the cervical spine, to completely replace the cervical intervertebral disc, and to treat cervical intervertebral disc diseases. There is still great potential for performance improvement and bone fusion improvement, but there are still many problems such as unstable fixation, inaccurate positioning, inconvenient operation, poor mechanical adaptability, easy recurrence after treatment, and unsatisfactory fusion effect. We are trying to make it more and more effective. The closer to people's expectations, in order to achieve a good clinical treatment effect.

发明内容Contents of the invention

本发明的目的在于提供一种用于颈椎的分体式椎间融合器，以解决现有技术中所存在的上述问题，使人工颈椎椎间融合器具有与天然椎间盘相适应的形状结构，具有合适的稳定性、准确的定位性以及更好的生物相容性，使椎间融合器携载药物并进行有效缓释，提高融合效果和植入的一次性成功率，避免出现移位和并发症的出现，使操作更加便捷，缩减治疗时间，减少翻修的可能性，降低手术风险，确保椎间融合器植入的运动性、安全性和可靠性。The purpose of the present invention is to provide a split type intervertebral fusion device for cervical vertebrae to solve the above-mentioned problems in the prior art, so that the artificial cervical intervertebral fusion device has a shape and structure compatible with the natural intervertebral disc, and has a suitable The stability, accurate positioning and better biocompatibility enable the intervertebral fusion device to carry drugs and perform effective sustained release, improve the fusion effect and the one-time success rate of implantation, and avoid displacement and complications The emergence of the device makes the operation more convenient, shortens the treatment time, reduces the possibility of revision, reduces the risk of surgery, and ensures the mobility, safety and reliability of the implantation of the intervertebral fusion device.

为实现上述目的，本发明提供的用于颈椎的分体式椎间融合器，包括融合器主体和辅助固定结构，其融合器主体包括主体框架、封闭填充腔、网板、弹性波纹板、固定球珠、条形槽、辅助固定螺纹孔、药物缓释孔等基本结构，其中，所述主体框架呈中空四面体，并具有前端板、后端板、左侧面、右侧面、顶面以及底面，所述左侧面、顶面、右侧面以及底面首尾相互连接为一整体而组成主体框架本体，所述前端板、后端板的上端均与网板相连，下端均与底面相连，所述主体框架内的下半部分设有封闭填充腔，所述封闭填充腔由所述前端板、底面、后端板、左侧面、右侧面以及网板围设而成，并填充有药物与移植骨混合物；所述主体框架内的上半部分设有弹性波纹板，所述弹性波纹板的左右两侧与所述左侧面、右侧面固定相连并沿前后方向贯穿所述主体框架内部，所述顶面和/或底面密布有凸出外表面的固定球珠，所述固定球珠呈半球形，植入后所述固定球珠的弧形球面直接与人体椎骨相抵接；所述左侧面、右侧面的外表面分别设有至少两个条形槽，分别为第一条形槽与第二条形槽，所述第一条形槽位于主体框架的上半部分，为非贯穿的下沉槽，所述第二条形槽位于主体框架的下半部分，为贯穿所处左侧面或右侧面的通槽，所述左侧面和右侧面的下半部分均布有可供药物缓释的网孔，所述左侧面和右侧面的上半部分无网孔，所述底面设有若干可供药物释放的圆形或椭圆形药物缓释孔，所述药物缓释孔的直径大于所述网孔的直径；所述前端板具有若干辅助固定螺纹孔，所述辅助固定螺纹孔至少具有四列并整齐排成两排设置，所述顶面的前端部设有与同列辅助固定螺纹孔竖向对齐的第一显影标记；所述辅助固定结构为两条形固定板，每个所述条形固定板上均于中间位置设有与同列辅助固定螺纹孔对应的两个螺钉孔，并且每个所述条形固定板的两端也均设有供螺钉穿设的螺钉孔，位于条形固定板两端的所述螺钉孔的孔道垂直于条形固定板或向远离融合器主体方向倾斜，靠近条形固定板的上端设有植入后可与第一显影标记重合的第二显影标记。In order to achieve the above object, the present invention provides a split type intervertebral fusion device for cervical spine, which includes a fusion device body and an auxiliary fixation structure. Basic structures such as beads, bar-shaped grooves, auxiliary fixing screw holes, drug slow-release holes, etc., wherein the main frame is a hollow tetrahedron, and has a front end plate, a rear end plate, a left side, a right side, a top surface and The bottom surface, the left side, the top surface, the right side and the bottom surface are connected end to end as a whole to form a main frame body. The upper ends of the front end plate and the rear end plate are connected to the mesh plate, and the lower ends are connected to the bottom surface. The lower half of the main body frame is provided with a closed filling cavity, which is surrounded by the front plate, the bottom surface, the rear end plate, the left side, the right side and the net plate, and is filled with Drug and bone graft mixture; the upper half of the main body frame is provided with elastic corrugated plates, and the left and right sides of the elastic corrugated plates are fixedly connected with the left and right sides and penetrate through the main body along the front and rear direction Inside the frame, the top surface and/or bottom surface are densely covered with fixed balls protruding from the outer surface. The fixed balls are hemispherical. The outer surfaces of the left side and the right side are respectively provided with at least two strip-shaped grooves, which are respectively a first strip-shaped groove and a second strip-shaped groove, and the first strip-shaped groove is located in the upper half of the main frame. It is a non-penetrating sinking groove, the second strip groove is located in the lower half of the main body frame, and is a through groove passing through the left side or the right side where it is located, and the lower half of the left side and the right side Some of them are evenly distributed with mesh holes for sustained drug release, the upper half of the left side and right side have no mesh, and the bottom surface is provided with a number of circular or oval drug sustained release holes for drug release , the diameter of the drug slow-release hole is greater than the diameter of the mesh; the front plate has a number of auxiliary fixing threaded holes, the auxiliary fixing threaded holes have at least four rows and are neatly arranged in two rows, the top surface The front end of the front end is provided with the first developing mark vertically aligned with the auxiliary fixing threaded holes of the same column; The two screw holes corresponding to the fixing threaded holes, and the two ends of each of the bar-shaped fixing plates are also provided with screw holes for screw penetration, and the channels of the screw holes at the two ends of the bar-shaped fixing plate are perpendicular to the bar Shaped fixing plate or inclined away from the main body of the fusion device, near the upper end of the bar-shaped fixing plate is provided with a second developing mark that can overlap with the first developing mark after implantation.

所述顶面和底面分别呈外凸弧形曲面，采用具有一定支撑性能的弹性材料制成，所述固定球珠采用镶嵌、一体成型、焊接等方式固定于所述顶面和/或底面，也可通过生物相容性粘合剂进行粘合固定，所述固定球珠采用与顶面相同或不同的材料制成，并且，所述固定球珠内含有少量（不足2%）可抑制细胞增殖的药物，所述固定球珠外表面被毛化处理并涂覆一层可促进假体融合的药物层，由此，即可促进植入初期融合器与颈椎接缝处的骨组织向椎间融合器内的长入而与融合器融合又可有效避免过度长入而使组织堆叠，避免造成椎间盘的再次突出，通过药物的合理搭配，进一步增强了椎间融合器的生物相容性和植入稳定性，治后不易复发、融合效果较好。The top surface and the bottom surface are respectively convex arc-shaped curved surfaces, which are made of elastic materials with a certain supporting performance, and the fixed balls are fixed on the top surface and/or bottom surface by means of inlaying, integral molding, welding, etc., Adhesive fixation is also possible with biocompatible adhesives, the fixation beads are made of the same or a different material than the top surface, and the fixation beads contain a small amount (less than 2%) of cell-inhibitory proliferating drug, the outer surface of the fixation ball is roughened and coated with a drug layer that can promote the fusion of the prosthesis, thus, it can promote the bone tissue at the seam of the fusion device and the cervical vertebrae at the initial stage of implantation to move toward the vertebral body. The groin in the intervertebral cage and the fusion with the cage can effectively avoid excessive groin and tissue stacking, and avoid re-herniation of the intervertebral disc. The reasonable combination of drugs further enhances the biocompatibility and stability of the intervertebral cage. Implantation stability, less recurrence after treatment, good fusion effect.

进一步的，所述弹性波纹板设置为2-3个，靠近顶面的弹性波纹板的波峰与所述顶面间的距离为0.3-0.7mm，各弹性波纹板协同作用，对顶面以及左侧面、右侧面起到支撑和弹性缓冲作用，避免融合器主体的沉陷和松动，同时又最大限度地允许顶面弹性变形，以便于植入操作和进一步确保植入的稳定性。Further, the number of elastic corrugated plates is 2-3, and the distance between the peak of the elastic corrugated plate near the top surface and the top surface is 0.3-0.7mm. The side and right sides play the role of support and elastic cushioning, avoiding the subsidence and loosening of the main body of the fusion device, and at the same time allow the elastic deformation of the top surface to the greatest extent, so as to facilitate the implantation operation and further ensure the stability of the implantation.

进一步的，所述第一条形槽位于网板与最下边弹性波纹板之间的位置，所述第一条形槽横截面呈梯形，即所述第一条形槽为外开口偏大的喇叭状，从而更利于组织的长入，所述第一条形槽内壁设有可促进组织生长的药物涂层，包括但不限于生长因子、细胞因子、细胞外基质分子、细胞附着序列、纳米羟基磷灰石、纳米羟基磷灰石和胶原的复合物等；所述第二条形槽位于网板下方位置，其横截面呈长方形，或者呈外开口小于内开口的梯形。Further, the first strip-shaped groove is located between the screen plate and the lowermost elastic corrugated plate, and the cross-section of the first strip-shaped groove is trapezoidal, that is, the first strip-shaped groove has a relatively large outer opening. Trumpet-shaped, which is more conducive to the growth of tissues. The inner wall of the first strip-shaped groove is provided with drug coatings that can promote tissue growth, including but not limited to growth factors, cytokines, extracellular matrix molecules, cell attachment sequences, nano Hydroxyapatite, a composite of nano-hydroxyapatite and collagen, etc.; the second strip-shaped groove is located below the mesh plate, and its cross section is rectangular, or trapezoidal with an outer opening smaller than an inner opening.

进一步的，所述前端中间位置设有一连接螺纹孔以供假体安装器快速连接到融合器上，所述连接螺纹孔的孔径大于两侧辅助固定螺纹孔的孔径，另外作为优选，也可在连接螺纹孔的左右边缘或者上下边缘设置弧形显影标记以便于准确定位。Further, a connecting threaded hole is provided at the middle position of the front end for the fast connection of the prosthesis installer to the fusion device. The diameter of the connecting threaded hole is larger than that of the auxiliary fixing threaded holes on both sides. The left and right edges or the upper and lower edges of the connecting threaded holes are provided with arc-shaped development marks for accurate positioning.

所述底面的药物缓释孔贯穿整个底面，如果底面也具有固定球珠，则所述药物缓释孔散布于相邻固定球珠之间，从而利于封闭填充腔内所填充药物的释放；所述顶面的各固定球珠之间具有间隙，所述间隙密布有贯穿所述顶面的网孔结构。The drug sustained-release holes on the bottom surface run through the entire bottom surface. If the bottom surface also has fixed balls, the drug sustained-release holes are scattered between adjacent fixed balls, thereby facilitating the release of the drug filled in the closed filling cavity; There are gaps between the fixed balls on the top surface, and the gaps are densely covered with a mesh structure penetrating the top surface.

作为优选，封闭填充腔内填充的所述药物为生物活性剂，可以是具体的药、生长因子、细胞因子、细胞外基质分子、蛋白质或其组合，包括但不限于成骨或软骨形成蛋白或肽、骨促进剂、骨消化剂、抗肿瘤剂、细胞引诱剂、附着剂、抗AIDS物质、抗生素、抗炎药、抗骨质疏松药、免疫抑制剂、抗病毒物质、酶抑制剂、激素、神经毒素、阿片类药物、抗组胺剂、肌肉松弛剂和抗帕金森病物质、抗痉挛剂和肌肉收缩剂、抗寄生虫和/或抗原生动物化合物、细胞-细胞外基质相互作用的调节剂(包括细胞生长抑制剂和抗粘附分子)、血管舒张剂、DNA、RNA或蛋白质合成抑制剂、抗高血压药、镇痛剂、局部麻醉剂、甾体和非甾体消炎剂、骨形态发生蛋白、抗血管生成因子、血管生成因子、抗分泌因子、抗凝剂和/或抗血栓剂、成像剂等。生物活性剂还包括RNA，如siRNA和破骨细胞刺激因子等；在一些实施例中，生物活性剂可以是停止、去除或降低骨生长抑制剂活性的因子；在一些实施例中，生物活性剂还可以为生长因子、细胞因子、细胞外基质分子或其片段或衍生物，例如细胞附着序列，如RGD等。封闭填充腔内所填充药物的布局方式为：贴近主体框架的药物以可促进组织生长或粘附为主，与其相邻的药物以抗炎、抑制组织过度生长为主，所述药物依附于移植骨或均布于移植骨之间，封闭填充腔内所填充的药物即可促进周围组织向椎间融合器内的长入而与融合器融合又可有效避免过渡长入而使组织堆叠，避免对周围神经的压迫。Preferably, the drug filled in the closed filling cavity is a bioactive agent, which can be specific drugs, growth factors, cytokines, extracellular matrix molecules, proteins or combinations thereof, including but not limited to osteogenic or chondrogenic proteins or Peptides, bone-promoting agents, bone-digesting agents, antitumor agents, cell attractants, adhesion agents, anti-AIDS substances, antibiotics, anti-inflammatory drugs, anti-osteoporosis drugs, immunosuppressants, antiviral substances, enzyme inhibitors, hormones , neurotoxins, opioids, antihistamines, muscle relaxants and antiparkinsonian substances, antispasmodic and muscle contraction agents, antiparasitic and/or antiprotozoal compounds, cell-extracellular matrix interactions Regulators (including cytostatics and anti-adhesion molecules), vasodilators, DNA, RNA, or protein synthesis inhibitors, antihypertensives, analgesics, local anesthetics, steroidal and nonsteroidal anti-inflammatory agents, osteoarthritis Morphogenetic proteins, antiangiogenic factors, angiogenic factors, antisecretory factors, anticoagulant and/or antithrombotic agents, imaging agents, and the like. Bioactive agents also include RNA, such as siRNA and osteoclast stimulating factor, etc.; in some embodiments, bioactive agents can be factors that stop, remove or reduce the activity of bone growth inhibitors; in some embodiments, bioactive agents It can also be growth factors, cytokines, extracellular matrix molecules or fragments or derivatives thereof, such as cell attachment sequences, such as RGD and the like. The layout of the drugs filled in the closed filling cavity is as follows: the drugs close to the main frame mainly promote tissue growth or adhesion, and the drugs adjacent to it are mainly anti-inflammatory and inhibit tissue overgrowth, and the drugs are attached to the graft. Bone or uniformly distributed between the grafted bones, the drug filled in the closed filling cavity can promote the growth of surrounding tissues into the intervertebral fusion cage, and fusion with the fusion cage can effectively avoid excessive growth and tissue stacking, avoiding Compression on peripheral nerves.

进一步的，所述辅助固定结构可通过螺钉与所述前端板上的辅助固定螺纹孔相连，通过第一显影标记与第二显影标记对辅助固定结构进行配合定位，并在确定完成目标位置的植入后经条形固定板两端的螺钉孔固定于相邻椎骨上。Further, the auxiliary fixing structure can be connected with the auxiliary fixing threaded hole on the front plate through screws, and the auxiliary fixing structure can be coordinated and positioned through the first developing mark and the second developing mark, and when the implantation at the target position is determined, After being inserted, it is fixed on the adjacent vertebrae through the screw holes at both ends of the strip-shaped fixing plate.

所述辅助固定结构的长度与所述融合器主体的宽度基本相同，在植入时可将辅助固定结构通过一根螺钉与融合器主体预连接，此时所述辅助固定结构可相对于融合器主体转动，当融合器主体植入至目标位置后，再将所述辅助固定结构旋转至正确位置，即第一显影标记与第二显影标记重合的位置，并固定其余的螺钉。The length of the auxiliary fixing structure is basically the same as the width of the fusion device body, and the auxiliary fixing structure can be pre-connected to the fusion device body through a screw during implantation. At this time, the auxiliary fixing structure can be relatively The main body is rotated, and when the main body of the fusion device is implanted to the target position, the auxiliary fixing structure is rotated to the correct position, that is, the position where the first and second development marks coincide, and the rest of the screws are fixed.

作为优选，所述前端板大于所述后端板，所述融合器主体的前端端面大于后端端面，即所述融合器主体由前往后具有逐渐变小的趋势。Preferably, the front end plate is larger than the rear end plate, and the front end surface of the fusion device body is larger than the rear end surface, that is, the fusion device body has a tendency to become smaller from front to back.

进一步地，所述辅助固定结构的长度与所述融合器主体的宽度基本相同，在植入时可将辅助固定结构通过一根螺钉与融合器主体预连接，此时所述辅助固定结构可相对于融合器主体转动，当融合器主体植入至目标位置后，所述辅助固定结构可旋转至正确位置，并通过螺钉将融合器主体固定于人体椎骨上。Further, the length of the auxiliary fixing structure is basically the same as the width of the fusion device body, and the auxiliary fixing structure can be pre-connected to the fusion device body through a screw during implantation. At this time, the auxiliary fixing structure can be relatively When the main body of the fusion device is rotated, after the main body of the fusion device is implanted at the target position, the auxiliary fixing structure can be rotated to the correct position, and the main body of the fusion device is fixed on the vertebrae of the human body through screws.

进一步地，所述左侧面、右侧面的外表面还设有第三条形槽，所述第三条形槽均位于主体框架的下半部分，为贯穿所处左侧面或右侧面的通槽，第三条形槽与所述第二条形槽平行设置并同时平行于所述第一条形槽，或者所述第三条形槽与第二条形槽交叉设置。Further, the outer surfaces of the left side and the right side are also provided with a third bar-shaped groove, and the third bar-shaped groove is located in the lower half of the main frame, and passes through the left side or the right side. The third strip-shaped groove is arranged parallel to the second strip-shaped groove and simultaneously parallel to the first strip-shaped groove, or the third strip-shaped groove is arranged to cross the second strip-shaped groove.

与现有技术相比，本发明具有以下有益技术效果：Compared with the prior art, the present invention has the following beneficial technical effects:

本发明解决了此前现有技术中的颈椎椎间融合器固定不稳、定位不准、不便操作、力学适应性差、治后复发、融合效果不理想等不足之处，满足了患者对治疗效果和医生手术操作便捷性的需求，其中，融合器主体顶面和/或底固定球珠的设置，使得固定球珠的弧形球面与人体椎骨相抵接时可实现温和固定，即可防止融合器的松动和脱落，又不易造成人体椎骨的损伤，使应用和操作更加安全可靠，固定球珠内即含有可抑制平滑肌细胞增殖的药物又于外表面涂覆有可促进假体融合的药物层，从而即可促进植入初期融合器与颈椎接缝处的骨组织向椎间融合器内的长入而与融合器融合又可有效避免过度长入而使组织堆叠，避免造成椎间盘的二次突出，进一步增强了椎间融合器的生物相容性和植入稳定性，治后不易复发、融合效果较好；位于左侧面、右侧面的多个条形槽，以及底面药物缓释孔的设置，不仅更利于周围组织的长入，同时还可以起到药物缓释的作用，配合填充腔内所填充药物的独特分布方式，即可促进周围组织向椎间融合器内的长入而与融合器融合又可有效避免过渡长入而使组织堆叠，避免对周围神经的压迫；另外，多个弹性波纹板的设置，使其对顶面以及左侧面、右侧面起到支撑和弹性缓冲作用，避免融合器主体的沉陷和松动，同时又最大限度地允许顶面弹性变形，以便于植入操作和进一步确保植入的稳定性，各结构合理配合形成有机整体，协同作用解决了现有技术中存在的上述不足之处，实现了良好的临床治疗效果。The present invention solves the shortcomings of the cervical intervertebral fusion device in the previous prior art, such as unstable fixation, inaccurate positioning, inconvenient operation, poor mechanical adaptability, recurrence after treatment, unsatisfactory fusion effect, etc., and satisfies the needs of patients for treatment effect and The needs of doctors for convenient operation, among them, the setting of the fixing ball on the top surface and/or bottom of the main body of the fusion cage makes it possible to achieve gentle fixation when the curved spherical surface of the fixing ball is in contact with the human vertebrae, which can prevent fusion cage Loosening and falling off, and it is not easy to cause damage to the human vertebrae, making the application and operation safer and more reliable. The fixation ball contains the drug that can inhibit the proliferation of smooth muscle cells and the outer surface is coated with a drug layer that can promote the fusion of the prosthesis. It can promote the ingrowth of the bone tissue at the joint between the fusion cage and the cervical spine at the initial stage of implantation into the intervertebral fusion cage, and the fusion with the fusion cage can effectively avoid excessive growth and tissue stacking, and avoid secondary herniation of the intervertebral disc. The biocompatibility and implantation stability of the intervertebral fusion device are further enhanced, the recurrence is not easy after treatment, and the fusion effect is better; the multiple strip grooves on the left side and the right side, and the drug slow-release holes on the bottom The setting is not only more conducive to the ingrowth of the surrounding tissues, but also can play a role in the sustained release of drugs. With the unique distribution of the drugs filled in the filling cavity, it can promote the ingrowth of the surrounding tissues into the intervertebral fusion cage. The fusion of fusion cages can effectively avoid overgrowth and tissue stacking, and avoid compression of peripheral nerves; in addition, the setting of multiple elastic corrugated plates makes it support and elastic for the top surface, left side, and right side The cushioning effect avoids the subsidence and loosening of the main body of the fusion device, and at the same time allows the elastic deformation of the top surface to the greatest extent, so as to facilitate the implantation operation and further ensure the stability of the implantation. The reasonable cooperation of each structure forms an organic whole, and the synergy solves the problem. The above-mentioned weak point that exists in the technology has realized good clinical treatment effect.

附图说明Description of drawings

图1是本发明融合器主体的整体结构示意图。Fig. 1 is a schematic diagram of the overall structure of the main body of the fusion device of the present invention.

图2是本发明融合器主体的剖面图。Fig. 2 is a sectional view of the main body of the fusion device of the present invention.

图3是本发明辅助固定结构的结构示意图。Fig. 3 is a structural schematic diagram of the auxiliary fixing structure of the present invention.

具体实施方式detailed description

下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他相关实施例，都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other relevant embodiments obtained by persons of ordinary skill in the art without making creative efforts fall within the protection scope of the present invention.

实施例1Example 1

参阅附图1-3所示，本发明所提出的一种用于颈椎的分体式椎间融合器，包括融合器主体1和辅助固定结构2，其融合器主体1包括主体框架、封闭填充腔3、网板4、弹性波纹板5、固定球珠6、条形槽、辅助固定螺纹孔7、药物缓释孔8等基本结构，其中，所述主体框架3呈中空四面体，并具有前端板9、后端板10、左侧面11、右侧面12、顶面13以及底面14，所述左侧面11、顶面13、右侧面12以及底面14首尾相互连接为一整体而组成主体框架本体，所述前端板9、后端板10的上端均与网板4相连，下端均与底面14相连，所述主体框架内的下半部分设有封闭填充腔3，所述封闭填充腔3由所述前端板9、底面14、后端板10、左侧面11、右侧面12以及网板4围设而成，并填充有药物与移植骨15混合物；所述主体框架内的上半部分设有弹性波纹板5，所述弹性波纹板5的左右两侧与所述左侧面11、右侧面12固定相连并沿前后方向贯穿所述主体框架内部，所述顶面13或底面14密布有凸出外表面的固定球珠6，所述固定球珠6呈半球形，植入后所述固定球珠6的弧形球面直接与人体椎骨相抵接，与传统的固定齿相比，在固定球珠6与人体椎骨相抵接时可实现温和固定，即可防止融合器主体1的松动和脱落，又不易造成人体椎骨的损伤，使应用更加安全可靠；如图1-2所示，所述左侧面11、右侧面12的外表面分别设有两个条形槽，分别为第一条形槽16与第二条形槽17，所述第一条形槽16位于主体框架的上半部分，所述第二条形槽17位于主体框架的下半部分，所述左侧面11和右侧面12的下半部分均布有可供药物缓释的网孔，所述左侧面11和右侧面12的上半部分无网孔，所述底面14设有若干可供药物释放的圆形或椭圆形药物缓释孔8，所述药物缓释孔8的直径大于所述网孔的直径，不仅可以起到药物缓释的作用，同时也利于周围组织的长入，所述前端板9具有若干辅助固定螺纹孔7，在该实施例中，所述辅助固定螺纹孔7设置有四列并整齐排成两排，所述顶面13的前端部设有与同列辅助固定螺纹孔7竖向对齐的第一显影标记18；所述辅助固定结构2为两条形固定板19，每个所述条形固定板19上均于中间位置设有与同列辅助固定螺纹孔7对应的两个螺钉孔20，并且每个所述条形固定板19的两端也均设有供螺钉21穿设的螺钉孔22，靠近条形固定板19的上端设有植入后可与第一显影标记18重合的第二显影标记23。Referring to accompanying drawings 1-3, a split type intervertebral fusion device for the cervical spine proposed by the present invention includes a fusion device main body 1 and anauxiliary fixing structure 2, and its fusion device main body 1 includes a main body frame and aclosed filling cavity 3. Basic structures such as stencil 4, elastic corrugated plate 5, fixed ball 6, strip groove, auxiliary fixing threaded hole 7, drug sustained release hole 8, wherein the main frame 3 is a hollow tetrahedron with a front end Plate 9, rear end plate 10, left side 11, right side 12, top surface 13 and bottom surface 14, described left side 11, top surface 13, right side 12 and bottom surface 14 are mutually connected as a whole Form the main frame body, the upper ends of the front end plate 9 and the rear end plate 10 are all connected to the mesh plate 4, and the lower ends are connected to the bottom surface 14, and the lower half of the main frame is provided with a closed filling cavity 3, and the closed The filling cavity 3 is surrounded by the front end plate 9, the bottom surface 14, the rear end plate 10, the left side 11, the right side 12 and the net plate 4, and is filled with a mixture of medicine and bone graft 15; the main frame The upper half of the inner part is provided with an elastic corrugated plate 5, and the left and right sides of the elastic corrugated plate 5 are fixedly connected with the left side 11 and the right side 12 and penetrate the inside of the main frame along the front and rear directions. Thesurface 13 or thebottom surface 14 are densely covered with fixedballs 6 protruding from the outer surface. The fixedballs 6 are hemispherical. Compared with the teeth, when the fixingball 6 is in contact with the human vertebrae, it can achieve gentle fixation, which can prevent the cage body 1 from loosening and falling off, and is not easy to cause damage to the human vertebrae, making the application safer and more reliable; as shown in Figure 1- 2, the outer surfaces of theleft side 11 and theright side 12 are respectively provided with two strip-shaped grooves, which are respectively the first strip-shapedgroove 16 and the second strip-shapedgroove 17, and the first strip-shapedgroove 16 is located in the upper half of the main body frame, the second bar-shapedgroove 17 is located in the lower half of the main body frame, and the lower half of theleft side 11 and theright side 12 are evenly distributed with nets for drug sustained release. Holes, the upper half of theleft side 11 and theright side 12 have no mesh, thebottom surface 14 is provided with a number of circular or oval drug sustained release holes 8 for drug release, the drug sustained release holes The diameter of 8 is larger than the diameter of the mesh, which can not only play the role of sustained drug release, but also facilitate the growth of surrounding tissues. The front end plate 9 has a number of auxiliary fixing threadedholes 7. In this embodiment, the The auxiliaryfixing screw holes 7 are arranged in four rows and neatly arranged in two rows, and the front end of thetop surface 13 is provided with a first developingmark 18 vertically aligned with the auxiliaryfixing screw holes 7 of the same row; theauxiliary fixing structure 2 It is a two-shapedfixing plate 19, and each of the strip-shapedfixing plates 19 is provided with twoscrew holes 20 corresponding to the auxiliary fixing threadedholes 7 in the same column at the middle position, and each of the strip-shapedfixing plates 19 Screw holes 22 for passingscrews 21 are also provided at both ends, and a second developingmark 23 that can overlap with the first developingmark 18 after implantation is provided near the upper end of the bar-shapedfixing plate 19 .

所述第一条形槽16为非贯穿的下沉槽，所述第二条形槽17为贯穿所处左侧面或右侧面的通槽，进一步的，所述第一条形槽16位于网板4与最下边弹性波纹板5之间的位置，所述第一条形槽16横截面呈梯形，即所述第一条形槽16为外开口偏大的喇叭状，从而更利于组织的长入，所述第一条形槽16内壁设有可促进组织生长的药物涂层，包括但不限于生长因子、细胞因子、细胞外基质分子、细胞附着序列、纳米羟基磷灰石、纳米羟基磷灰石和胶原的复合物等；所述第二条形槽17位于网板4下方位置，其横截面呈长方形，或者呈外开口小于内开口的梯形，从而在允许组织长入的同时更利于封闭填充腔内所填充药物的释放。The first strip-shapedgroove 16 is a non-penetrating sinking groove, and the second strip-shapedgroove 17 is a through groove that runs through the left or right side of the location. Further, the first strip-shapedgroove 16 Located between thenet plate 4 and the lowermost elasticcorrugated plate 5, the cross section of thefirst strip groove 16 is trapezoidal, that is, thefirst strip groove 16 is in the shape of a trumpet with a relatively large outer opening, which is more conducive to For tissue growth, the inner wall of thefirst strip groove 16 is provided with a drug coating that can promote tissue growth, including but not limited to growth factors, cytokines, extracellular matrix molecules, cell attachment sequences, nano-hydroxyapatite, A composite of nano-hydroxyapatite and collagen, etc.; the second strip-shapedgroove 17 is located below thenet plate 4, and its cross-section is rectangular, or trapezoidal in which the outer opening is smaller than the inner opening, thereby allowing tissue to grow into At the same time, it is more conducive to the release of the medicine filled in the closed filling cavity.

所述顶面13和底面14分别呈外凸弧形曲面，采用具有一定支撑性能的弹性材料制成，所述固定球珠6采用镶嵌、一体成型、焊接等方式固定于所述顶面13或底面14，也可通过生物相容性粘合剂进行粘合固定，所述固定球珠6采用与顶面13或底面14相同或不同的材料制成，并且，所述固定球珠6内含有少量（不足2%）可抑制细胞增殖的药物，包括西罗莫司、他克莫司、艾罗莫司、免疫抑制剂ABT-578、C-蛋白酶抑制剂、3-羟化酶抑制剂、甲基强的松龙、地塞米松、咪唑立宾、雷帕霉素、紫杉醇及其衍生物、放线菌素、阿霉素、更生霉素、丝裂霉素、长春新碱及其衍生物、他汀类药物、2-氯去氧腺苷、核酶、巴马司他、普罗布可、雌二醇类等活性药物中的任一种或任几种，所述固定球珠6外表面被毛化处理并涂覆一层可促进假体融合的药物层，包括骨形态发生蛋白、干细胞、CD31抗体、CD133抗体、CD34抗体、CD45抗体、Klotho蛋白、细胞外基质（ECM）、胶质细胞源性的神经营养因子和内皮生长因子(VEGF)、血管生长因子中的任一种或任几种，由此，即可促进植入初期融合器与颈椎接缝处的骨组织向椎间融合器内的长入而与融合器融合又可有效避免过度长入而使组织堆叠，避免造成椎间盘的再次突出，通过药物的合理搭配，进一步增强了椎间融合器的生物相容性和植入稳定性，治后不易复发、融合效果较好。Thetop surface 13 and thebottom surface 14 are respectively convex arc-shaped curved surfaces, and are made of elastic materials with a certain supporting performance. The fixedball 6 is fixed on thetop surface 13 or the Thebottom surface 14 can also be bonded and fixed by a biocompatible adhesive, and the fixedball 6 is made of the same or different material as thetop surface 13 or thebottom surface 14, and the fixedball 6 contains A small amount (less than 2%) of drugs that can inhibit cell proliferation, including sirolimus, tacrolimus, eirolimus, immunosuppressant ABT-578, C-proteinase inhibitors, 3-hydroxylase inhibitors, Methylprednisolone, dexamethasone, mizoribine, rapamycin, paclitaxel and its derivatives, actinomycin, doxorubicin, dactinomycin, mitomycin, vincristine and its derivatives Any one or any several of active drugs such as drugs, statins, 2-chlorodeoxyadenosine, ribozyme, batimastat, probucol, estradiol, etc. The surface is roughened and coated with a drug layer that can promote the fusion of the prosthesis, including bone morphogenetic protein, stem cells, CD31 antibody, CD133 antibody, CD34 antibody, CD45 antibody, Klotho protein, extracellular matrix (ECM), glue Neurotrophic factor, endothelial growth factor (VEGF) and vascular growth factor derived from cytoplasmic cells can promote the bone tissue at the joint between the fusion cage and the cervical spine to move toward the vertebrae. The groin in the intervertebral cage and the fusion with the cage can effectively avoid excessive groin and tissue stacking, and avoid re-herniation of the intervertebral disc. The reasonable combination of drugs further enhances the biocompatibility and stability of the intervertebral cage. Implantation stability, less recurrence after treatment, good fusion effect.

进一步的，所述弹性波纹板5设置为2-3个，靠近顶面13的弹性波纹板5的波峰与所述顶面间的距离为0.3-0.7mm，各弹性波纹板5协同作用，对顶面13以及左侧面11、右侧面12起到支撑和弹性缓冲作用，避免融合器主体1的沉陷和松动，同时又最大限度地允许顶面13弹性变形，以便于植入操作和进一步确保植入的稳定性。Further, the number of elasticcorrugated plates 5 is set to 2-3, and the distance between the peak of the elasticcorrugated plates 5 close to thetop surface 13 and the top surface is 0.3-0.7mm, and the elasticcorrugated plates 5 cooperate to Thetop surface 13, theleft side 11, and theright side 12 play a supporting and elastic buffering role, avoiding the subsidence and loosening of the fuser body 1, and at the same time allowing the elastic deformation of thetop surface 13 to the greatest extent, so as to facilitate the implantation operation and further Ensure the stability of the implant.

进一步的，所述前端板9中间位置设有一连接螺纹孔24以供假体安装器快速连接到融合器上，所述连接螺纹孔24的孔径大于两侧辅助固定螺纹孔7的孔径。Further, a connection threadedhole 24 is provided in the middle of the front end plate 9 for the fast connection of the prosthesis installer to the cage, and the diameter of the connection threadedhole 24 is larger than that of the auxiliary fixing threadedholes 7 on both sides.

所述底面14的药物缓释孔8贯穿整个底面14，如果底面14也具有固定球珠6，则所述药物缓释孔散布于相邻固定球珠6之间，从而利于封闭填充腔内所填充药物的释放；所述顶面13的各固定球珠6之间具有间隙，所述间隙密布有贯穿所述顶面13的网孔结构。The drug slow-release holes 8 of thebottom surface 14 run through theentire bottom surface 14. If thebottom surface 14 also has fixedballs 6, the drug slow-release holes are scattered between adjacentfixed balls 6, thereby facilitating the sealing of all the holes in the filling cavity. The release of the filling drug; there are gaps between thefixed balls 6 on thetop surface 13 , and the gaps are densely covered with a mesh structure that runs through thetop surface 13 .

作为优选，封闭填充腔3内填充的所述药物为生物活性剂，可以是具体的药、生长因子、细胞因子、细胞外基质分子、蛋白质或其组合，包括但不限于成骨或软骨形成蛋白或肽、骨促进剂、骨消化剂、抗肿瘤剂、细胞引诱剂、附着剂、抗AIDS物质、抗生素、抗炎药、抗骨质疏松药、免疫抑制剂、抗病毒物质、酶抑制剂、激素、神经毒素、阿片类药物、抗组胺剂、肌肉松弛剂和抗帕金森病物质、抗痉挛剂和肌肉收缩剂、抗寄生虫和/或抗原生动物化合物、细胞-细胞外基质相互作用的调节剂(包括细胞生长抑制剂和抗粘附分子)、血管舒张剂、DNA、RNA或蛋白质合成抑制剂、抗高血压药、镇痛剂、局部麻醉剂、甾体和非甾体消炎剂、骨形态发生蛋白、抗血管生成因子、血管生成因子、抗分泌因子、抗凝剂和/或抗血栓剂、成像剂等。生物活性剂还包括RNA，如siRNA和破骨细胞刺激因子等；在一些实施例中，生物活性剂可以是停止、去除或降低骨生长抑制剂活性的因子；在一些实施例中，生物活性剂还可以为生长因子、细胞因子、细胞外基质分子或其片段或衍生物，例如细胞附着序列，如RGD等。封闭填充腔3内所填充药物的布局方式为：贴近主体框架的药物以可促进组织生长或粘附为主，与其相邻的药物以抗炎、抑制组织过度生长为主，所述药物依附于移植骨或均布于移植骨之间，封闭填充腔3内所填充的药物即可促进周围组织向椎间融合器内的长入而与融合器融合又可有效避免过渡长入而使组织堆叠，避免对周围神经的压迫。Preferably, the medicine filled in the closed fillingcavity 3 is a bioactive agent, which can be a specific medicine, growth factor, cytokine, extracellular matrix molecule, protein or a combination thereof, including but not limited to osteogenic or chondrogenic proteins or peptides, bone-promoting agents, bone-digesting agents, antitumor agents, cell attractants, adhesion agents, anti-AIDS substances, antibiotics, anti-inflammatory drugs, anti-osteoporosis drugs, immunosuppressants, antiviral substances, enzyme inhibitors, Hormones, neurotoxins, opioids, antihistamines, muscle relaxants and antiparkinsonian substances, antispasmodic and muscle contraction agents, antiparasitic and/or antiprotozoal compounds, cell-extracellular matrix interactions Regulators (including cytostatics and anti-adhesion molecules), vasodilators, DNA, RNA or protein synthesis inhibitors, antihypertensives, analgesics, local anesthetics, steroidal and nonsteroidal anti-inflammatory agents, Bone morphogenetic protein, antiangiogenic factor, angiogenic factor, antisecretory factor, anticoagulant and/or antithrombotic agent, imaging agent, etc. Bioactive agents also include RNA, such as siRNA and osteoclast stimulating factor, etc.; in some embodiments, bioactive agents can be factors that stop, remove or reduce the activity of bone growth inhibitors; in some embodiments, bioactive agents It can also be growth factors, cytokines, extracellular matrix molecules or fragments or derivatives thereof, such as cell attachment sequences, such as RGD and the like. The layout of the medicines filled in the closed fillingcavity 3 is as follows: the medicines close to the main frame mainly promote tissue growth or adhesion, and the medicines adjacent to it are mainly anti-inflammatory and inhibit tissue overgrowth, and the medicines are attached to The grafted bone may be evenly distributed between the grafted bones, and the drug filled in the closed fillingcavity 3 can promote the growth of surrounding tissues into the intervertebral cage, and fusion with the cage can effectively avoid excessive growth and tissue stacking , to avoid compression of peripheral nerves.

进一步的，所述辅助固定结构2可通过螺钉与所述前端板9上的辅助固定螺纹孔7相连，通过第一显影标记18与第二显影标记23对辅助固定结构2进行配合定位，并在确定完成目标位置的植入后经条形固定板19两端的螺钉孔22固定于相邻椎骨上，作为优选，位于条形固定板19两端的所述螺钉孔22的孔道垂直于条形固定板19或向远离融合器主体1方向倾斜，Further, theauxiliary fixing structure 2 can be connected with the auxiliary fixing threadedhole 7 on the front plate 9 through screws, and theauxiliary fixing structure 2 can be coordinated and positioned through the first developingmark 18 and the second developingmark 23, and then After confirming that the implantation of the target position is completed, the screw holes 22 at both ends of the strip-shapedfixing plate 19 are fixed on the adjacent vertebrae. 19 or tilt away from the fuser main body 1,

所述辅助固定结构2的长度与所述融合器主体1的宽度基本相同，在植入时可将辅助固定结构2通过一根螺钉与融合器主体1预连接，此时所述辅助固定结构2可相对于融合器主体1转动，当融合器主体1植入至目标位置后，再将所述辅助固定结构2旋转至正确位置，即第一显影标记18与第二显影标记23重合的位置，并固定其余的螺钉，将融合器主体1固定于人体椎骨上。The length of theauxiliary fixing structure 2 is basically the same as the width of the fusion device main body 1, and theauxiliary fixing structure 2 can be pre-connected to the fusion device main body 1 by a screw during implantation. At this time, theauxiliary fixing structure 2 It can be rotated relative to the fusion device main body 1. After the fusion device main body 1 is implanted at the target position, theauxiliary fixing structure 2 is rotated to the correct position, that is, the position where thefirst visualization mark 18 and thesecond visualization mark 23 overlap. And fix the rest of the screws, and fix the fuser main body 1 on the vertebrae of the human body.

实施例2Example 2

参阅附图1-2，本实施例与实施例1结构基本相同，不同的是，在该实施例中，所述顶面13和底面14均密布有凸出外表面的固定球珠6，所述固定球珠6采用镶嵌、一体成型、焊接等方式固定于所述顶面13和底面14，也可通过生物相容性粘合剂进行粘合固定；所述弹性波纹板5也可设置为1个，且该弹性波纹板5的波峰与所述顶面间的距离为0.2-0.6mm，弹性波纹板5对顶面13以及左侧面11、右侧面12起到支撑和弹性缓冲作用，避免融合器主体1的沉陷和松动，同时又最大限度地允许顶面13弹性变形，以便于植入操作和进一步确保植入的稳定性。Referring to accompanying drawings 1-2, the structure of this embodiment is basically the same as that of Embodiment 1. The difference is that in this embodiment, thetop surface 13 and thebottom surface 14 are densely covered with fixedballs 6 protruding from the outer surface. The fixedball 6 is fixed on thetop surface 13 and thebottom surface 14 by inlaying, integral molding, welding, etc., and can also be bonded and fixed by a biocompatible adhesive; the elasticcorrugated plate 5 can also be set as 1 and the distance between the crest of the elasticcorrugated plate 5 and the top surface is 0.2-0.6mm, the elasticcorrugated plate 5 supports and elastically cushions thetop surface 13, theleft side 11, and theright side 12, The subsidence and loosening of the fusion device main body 1 are avoided, and at the same time, the elastic deformation of thetop surface 13 is allowed to the greatest extent, so as to facilitate the implantation operation and further ensure the stability of the implantation.

作为优选，在该实施例中，也可在连接螺纹孔24的左右边缘或者上下边缘设置弧形显影标记以便于准确定位。As a preference, in this embodiment, arc-shaped developing marks can also be provided on the left and right edges or the top and bottom edges of the connecting threadedhole 24 to facilitate accurate positioning.

实施例3Example 3

参阅附图1-3，本实施例与实施例1或实施例2结构基本相同，不同的是，在该实施例中，所述左侧面11、右侧面12的外表面分别设有三个条形槽，分别为第一条形槽16、第二条形槽与第三条形槽，与实施例1相同，所述第一条形槽16位于主体框架的上半部分，为非贯穿的下沉槽，在该实施例中，所述第二条形槽和第三条形槽均位于主体框架的下半部分，为贯穿所处左侧面或右侧面的通槽，所述第二条形槽与第三条形槽平行设置并同时平行于所述第一条形槽16，或者所述第二条形槽与第三条形槽交叉设置。Referring to accompanying drawings 1-3, the structure of this embodiment is basically the same as that of Embodiment 1 orEmbodiment 2. The difference is that in this embodiment, the outer surfaces of theleft side 11 and theright side 12 are respectively provided with three The strip-shaped grooves are respectively the first strip-shapedgroove 16, the second strip-shaped groove and the third strip-shaped groove, which are the same as in Embodiment 1. The first strip-shapedgroove 16 is located in the upper half of the main frame and is non-penetrating In this embodiment, the second strip-shaped slot and the third strip-shaped slot are both located in the lower half of the main frame, and are through slots running through the left side or right side where they are located. The second strip-shaped groove is arranged parallel to the third strip-shaped groove and is parallel to the first strip-shapedgroove 16 , or the second strip-shaped groove is arranged to intersect with the third strip-shaped groove.

进一步地，所述前端板9大于所述后端板10，所述融合器主体1的前端端面大于后端端面，即所述融合器主体1由前往后具有逐渐变小的趋势，确保融合器主体1与人体颈椎椎间空间一致，使其具有更好的顺应性和稳定性。Further, the front end plate 9 is larger than therear end plate 10, and the front end face of the fusion device main body 1 is larger than the rear end end face, that is, the fusion device main body 1 has a tendency to become smaller from front to back, ensuring that the fusion device The main body 1 is consistent with the intervertebral space of human cervical vertebrae, so that it has better compliance and stability.

对于本领域技术人员而言，显然本发明不限于上述示范性实施例的细节，而且在不背离本发明的精神或基本特征的情况下，能够以其他的具体形式或其组合实现本发明。因此，非限制性的，本发明的保护范围由所附权利要求书而不是上述说明书限定，因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。It is obvious to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms or combinations thereof without departing from the spirit or essential characteristics of the present invention. Therefore, without limitation, the scope of protection of the present invention is defined by the appended claims rather than the above description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced in the present invention.

进一步地，作为本领域技术人员所通晓的，该实施例也可额外设置其它结构以在植入或取出时利于进行必要的控制和操作，以不脱离本发明的发明宗旨且各结构间不发生结构干涉、本领域技术人员可以实施为准。Further, as those skilled in the art are familiar with, this embodiment can additionally be provided with other structures to facilitate necessary control and operation during implantation or removal, so as not to depart from the gist of the present invention and to avoid occurrences between structures. Structural interference can be implemented by those skilled in the art.

此外，应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施例中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。In addition, it should be understood that although this specification is described according to implementation modes, not each implementation mode only contains an independent technical solution, and this description in the specification is only for clarity, and those skilled in the art should take the specification as a whole , the technical solutions in the various embodiments can also be properly combined to form other implementations that can be understood by those skilled in the art.

Claims

1. The utility model provides a split type interbody fusion cage for cervical vertebra, includes fusion cage main part and supplementary fixed knot structure, its characterized in that, the fusion cage main part includes main body frame, seals packing chamber, otter board, elastic corrugated plate, fixed ball, bar groove, supplementary fixed screw hole, medicine slowly-releasing hole, wherein, main body frame is the structure of cavity tetrahedron to have front end plate, back end plate, left surface, right flank, top surface and bottom surface, left surface, top surface, right surface and bottom surface end to end interconnect constitute main body frame body, front end plate, back end plate's upper end all link to each other with the otter board, the lower extreme all links to each other with the bottom surface, the latter half in the main body frame is equipped with seals packing chamber, seals packing chamber by front end plate, bottom surface, back end plate, left surface, right surface and otter board enclose to be formed, and fill medicine and transplanting bone mixture; the upper half part in the main body frame is provided with an elastic corrugated plate, the left side and the right side of the elastic corrugated plate are fixed with the left side surface and the right side surface and penetrate through the inside of the main body frame along the front-back direction, and fixing balls protruding out of the outer surface are densely distributed on the top surface and/or the bottom surface and are hemispherical; the outer surfaces of the left side surface and the right side surface are respectively provided with at least two strip-shaped grooves which are respectively a first strip-shaped groove and a second strip-shaped groove, the first strip-shaped groove is positioned on the upper half part of the main body frame, the second strip-shaped groove is positioned on the lower half part of the main body frame, meshes for slowly releasing medicines are uniformly distributed on the lower half parts of the left side surface and the right side surface, the bottom surface is provided with a plurality of circular or elliptical medicine slow release holes for releasing medicines, the diameter of the medicine slow release holes is larger than that of the meshes, the front end plate is provided with a plurality of auxiliary fixing threaded holes, the auxiliary fixing threaded holes are provided with four rows and are orderly arranged into two rows, and the front end part of the top surface is provided with a first developing mark vertically aligned with the auxiliary fixing threaded holes in the same row; supplementary fixed knot constructs for two bar fixed plates, every all be equipped with in the intermediate position on the bar fixed plate with two screw holes that the supplementary fixed screw hole that is listed as corresponds, and every the both ends of bar fixed plate also all are equipped with the screw hole that supplies the screw to wear to establish, the upper end that is close to the bar fixed plate is equipped with the second development mark that can coincide with first development mark after the implantation.

3. The intersomatic cage of claim 1, wherein the top and bottom surfaces are convex curved surfaces and made of an elastic material with supporting properties, the fixing beads are fixed to the top or bottom surfaces by means of embedding, integral molding, welding, or by means of a biocompatible adhesive, and the fixing beads are made of a material the same as or different from the top or bottom surfaces, and contain a drug for inhibiting cell proliferation, and the outer surface of the fixing beads is roughened and coated with a drug layer for promoting the fusion of the prosthesis.

4. The intersomatic cage of claim 1, wherein the number of the corrugated plates is 2-3, the distance between the wave crest of the corrugated plate near the top surface and the top surface is 0.3-0.7mm, and the corrugated plates cooperate to support and elastically cushion the top surface, the left side surface and the right side surface.

5. An intersomatic cage according to any one of claims 1 to 4, wherein the front end plate has a threaded coupling hole at a central position thereof for quick connection of a prosthesis mounting device to the cage, the threaded coupling hole having a diameter greater than the diameter of the auxiliary fastening holes at opposite sides thereof.

6. The intersomatic cage according to any one of claims 1 to 5, wherein the drug releasing holes of the bottom surface extend through the entire bottom surface, and are interspersed between adjacent fixing beads when the bottom surface is also provided with fixing beads; gaps are arranged among the fixed balls on the top surface, and mesh structures penetrating through the top surface are densely distributed in the gaps.

7. The intervertebral fusion device as claimed in any one of claims 1 to 4, wherein the drug filled in the closed filling cavity is a bioactive agent, which may be a specific drug, growth factor, cytokine, extracellular matrix molecule, protein or combination thereof, and the arrangement of the drug filled in the closed filling cavity is as follows: the medicine close to the main body frame mainly promotes the growth or adhesion of tissues, the medicine adjacent to the main body frame mainly resists inflammation and inhibits the overgrowth of tissues, and the medicine is attached to the transplanted bones or uniformly distributed among the transplanted bones.

8. The intervertebral fusion device according to any one of claims 1 to 4, wherein the auxiliary fixing structure is connected with the auxiliary fixing threaded hole on the front end plate through a screw, and the auxiliary fixing structure is cooperatively positioned through the first visualization mark and the second visualization mark and fixed on the adjacent vertebrae through the screw holes at the two ends of the strip-shaped fixing plate after the implantation of the target position is determined.